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| Tracking Information | |||||||||
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| First Received Date ICMJE | August 31, 2005 | ||||||||
| Last Updated Date | March 18, 2007 | ||||||||
| Start Date ICMJE | August 2005 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE | |||||||||
| Change History | Complete list of historical versions of study NCT00143767 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Magnetic Resonance Imaging of Brain Development in Attention Deficit Hyperactivity Disorder | ||||||||
| Official Title ICMJE | Magnetic Resonance Imaging of Brain Development in Attention Deficit Hyperactivity Disorder | ||||||||
| Brief Summary | The primary purpose of this study is to investigate brain whether ADHD represents a disruption or a delay of brain development. Children and adolescents both with and without ADHD are asked to participate in several MRI sessions, two years apart. This will allow us to chart brain development over time, both in typical development and ADHD, and therefore to address whether ADHD represents a disruption or a delay of typical brain development. |
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| Detailed Description | Attention Deficit Hyperactivity Disorder (ADHD) is a common and impairing neuropsychiatric disorder of childhood, occurring in 3 to 5% of all school-age children. This disorder is associated with greater risks for low academic achievement, school dropouts, poor family and peer relations, aggression, substance abuse, driving accidents and chronic problems in adult adaptation. As such, it has an enormous impact on the utilization of medical and health care services, and the direct and indirect costs of this disorder are high. However, in a large number of children symptoms dissipate as they grow up and they go on to function normally and lead typical lives. This has lead to speculation that ADHD may not so much represent a disruption, as a delay of brain development. This aim of this study is to address this issue. There is a growing body of research supporting the existence of deficits in brain anatomy associated with ADHD, with evidence of reductions in overall brain size, cortical gray matter and subcortical structures. However, reported effect sizes are small and results not always consistent. Anatomical MRI studies may be easily confounded, as brain development is complex and associated with both progressive and regressive changes in brain anatomy. In this study, we propose to combine longitudinal data from a large cohort of children and adolescents with state-of-the-art imaging methods (including diffusion tensor imaging and voxelbased morphometry) to investigate brain development in ADHD. This will allow us to address the question whether ADHD represents a disruption or a delay of brain development. |
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| Study Phase | |||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Natural History, Longitudinal, Case Control, Prospective Study | ||||||||
| Condition ICMJE | Attention Deficit Hyperactivity Disorder | ||||||||
| Intervention ICMJE | |||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Enrollment ICMJE | 400 | ||||||||
| Completion Date | |||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Inclusion Criteria for Subjects with ADHD:
Inclusion Criteria for Controls:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 6 Years to 20 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Netherlands | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00143767 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | METC 05/036 | ||||||||
| Study Sponsor ICMJE | UMC Utrecht | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | UMC Utrecht | ||||||||
| Verification Date | March 2007 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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